EDP-494-001: A Study of EDP-494 in Healthy Subjects and Hepatitis C Patients

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: EDP-494; Drug: Placebo

• Registration Number: NCT02652377
• Lead Sponsor: Enanta Pharmaceuticals, Inc

Brief Summary

This randomized, double-blind study will assess the safety, pharmacokinetics and efficacy of a single and multiple dose(s) of orally QD administered EDP-494 in healthy volunteers (HV) and in treatment-naive subjects with GT1/3 chronic hepatitis C (CHC) infection.

Detailed Description

The first phase explores single ascending doses of EDP-494 (active drug or placebo) in healthy subjects. A 'fasted' vs 'fed' two-part cohort will also assess food effect.

The second phase involves multiple ascending doses (active drug or placebo) for 14 days in healthy subjects.

The third, proof of concept, phase will assess two different doses for 14 days each in Hepatitis C patients.

Each cohort within each phase will consist of 8 subjects randomized to either EDP-494 or placebo in a 3 to 1 ratio, with the exception of the food effect cohort, which will consist of 10 subjects randomised in a 4 to 1 ratio.

Study Timeline

• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-07
• Study Start: 2016-01-10
• Study First Posted: 2016-01-11
• Primary Completion: 2016-12-27
• Study Completion: 2016-12-27
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EDP-494 SAD Cohorts	EDP-494	EDP-494, oral 50 mg, 100mg, 200mg, 400mg and 800 mg, capsules, once daily in one single administration
EDP-494 SAD Placebo Cohort	Placebo	-
EDP-494 MAD/POC Cohorts	EDP-494	EDP-494, oral 200mg, 400mg and 800 mg, capsules, once daily for 14 days
EDP-494 MAD/POC Placebo Cohort	Placebo	-

Primary Outcome Measures

Name	Time	Method
Composite number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, and abnormal clinical laboratory results administered to healthy volunteers and multiple doses of EDP-494	From screening and baseline to the 4 week follow-up visit	Tabulation of the number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results (including chemistry, hematology, and urine).; Administered to healthy volunteers and multiple doses of EDP-494 administered to healthy volunteers and subjects with Chronic Hepatitis C (CHC) genotype 1 and 3 infection

Secondary Outcome Measures

Name	Time	Method
Change from baseline in plasma HCV RNA (log10 IU/mL)	Baseline up to 14 days
AUC	Day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 5, 7, 9, 12: 0 (Predose);Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72, 96, 120, 144 and 168 hrs postdose	EDP-494 and metabolites
Amino Acid Changes in HCV polymerase NS5b	Baseline up to 3 months
Cmax	Day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 5, 7, 9, 12: 0 (Predose); Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72, 96, 120, 144 and 168 hrs postdose	EDP-494 and metabolites

Trial Locations

Locations (1)

Auckland Clinical Studies Ltd; 🇳🇿 Auckland, New Zealand